FDA warns against using baby neck floats after child dies

The United States Food and Drug Administration warns parents, caregivers and health care providers not to use cervical floats with babies for water therapy procedures after the death of a child and the hospitalization of another.

The warning was particularly aimed at babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome or cerebral palsy.

The FDA said the risks include death from drowning and suffocation, fatigue and injury to a baby’s neck. Babies with special needs such as spina bifida or SMA type 1 may be at increased risk of serious injury.

The FDA said in a statement that it is aware of one baby who died and one baby hospitalized due to the use of baby floats. In both cases, the babies were injured while their caregivers were not directly supervising them.

Although the FDA has said it believes deaths or serious injuries from cervical floaters are rare, healthcare providers, parents, and caregivers should be aware that these events can and do occur. It is also possible that some cases have not been reported to the FDA.

A d

Neck floats are inflatable plastic rings that can be worn around a baby’s neck and allow babies to float freely in water. Some neck floats are marketed for babies as young as two weeks old or premature babies and are designed to cradle a baby’s head while their body moves freely in the water. Parents and caregivers have used these products while bathing a baby, while their baby is swimming, and as a tool for physiotherapy (water therapy intervention) for babies with developmental delays or disabilities.

The FDA said it has been made aware that some companies are marketing the floaters as a water treatment tool without FDA clearance or approval and are responding accordingly.

The companies claim the products increase muscle tone, improve flexibility and range of motion, increase lung capacity, improve sleep quality, and increase brain and nervous system stimulation. But the safety and effectiveness of neck floats for building strength, promoting motor development, or as a physical therapy tool have not been established, the FDA warned.

A d

Recommendations for Parents and Guardians

  • Do not use baby neck floats for a water therapy procedure. Use of these products, particularly with babies with developmental delays or special needs, could result in death or serious injury.

  • Be aware that the use of neck floats on babies with special needs may lead to an increased risk of neck strain and injury.

  • Please be aware that these neck floats have not been evaluated by the FDA and we are not aware of any demonstrated benefit of using neck floats for water therapy procedures.

  • If a baby or someone in your care is injured by a neck floater, we encourage you to report it to the FDA. Your report, along with information from other sources, can help the FDA identify and better understand the risks associated with medical devices.

Recommendations for Health Care Providers

  • Review this safety communication with co-workers, care teams, parents and caregivers of babies using neck floats for a water therapy procedure to ensure they are aware of the potential risk of death or injury associated with neck floats.

  • Discourage the use of neck floats in babies with these conditions.

  • If a patient experiences a problem with a neck float, report it to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Reporting Issues to the FDA

If you experience any adverse reactions associated with the use of neck floats, we encourage you to voluntarily file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities subject to FDA user facility reporting requirements must follow the reporting procedures established by their facilities.

Please include the following information in your reports:

  • Device name (brand name)

  • Name of manufacturer, importer and/or distributor

  • Details of adverse event and medical and/or surgical procedures (if applicable)

If you believe a medical device is being marketed outside the scope of its FDA approval or clearance, you may report that allegation through the FDA regulatory misconduct allegation process. You can also contact your local FDA Consumer Complaints Coordinator for assistance with this process.

Copyright 2022 by WJXT News4JAX – All Rights Reserved.

Comments are closed.